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TM "Rehabilitimed" TUTOR-6K-VU UNI Left
REABILITIMED TOV · Model TUTOR-6K-VU UNI Left · UDI-DI 04823097722787
10
510(k) clearances
48
Adverse events
1
Recalls
428
Facilities
Description
Black wrist-hand orthosis, designed for complete fixation of the radiocarpal joint and thumb, provides external semi-rigid dosed fixation of the distal third of the forearm and radiocarpal joint, and the thumb in the abduction position. Reinforced with two metal profiled splints, one at an angle of 60 degrees to the hand relative to the forearm, located along the palm, the second at an angle of 0 degrees to the thumb in the abduction position. Made of multilayer material with a cotton layer to the body and polyamide on the outside.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-18 | North Coast Medical Inc | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.